Method and article for packaging dosed products

ABSTRACT

The present invention provides a child-resistant package for a dosed-form product having a blister layer, a rupturable layer disposed adjacent the blister layer, the rupturable layer and the blister layer together defining at least one cavity, a diaphragm layer for resisting passage of a dose, the diaphragm layer disposed adjacent the rupturable layer on a side of the rupturable layer opposite the blister layer, and a backing layer having at least one moveable tab corresponding to the at least one cavity, the backing layer disposed adjacent the diaphragm layer on a side of the diaphragm layer opposite the rupturable layer. Also included are methods of packaging dosed products in accordance with the invention.

BACKGROUND OF THE INVENTION

[0001] It is known to use blister packages to contain small articlessuch as pharmaceutical or dose form products. These packages allow theuser to access the product by applying pressure to the blister to forcethe product from an individual blister or capsule through a rupturablelayer.

[0002] Known blister packages comprise a first sheet of transparent ortranslucent thermoformable material such as polyvinyl chloride orpolystyrene having a plurality of flexible blisters or blisterspreformed therein and projecting outwardly from one surface to defineseparate compartments for individual doses of a product, typically asingle tablet or capsule, and a second sheet to cover the product. Thesecond sheet is often made from a rupturable foil or a paper-foilcombination so that the user can push the product from the blister sideout through the foil. This construction did not offer much in the way ofchild resistance, and presented a potential hazard to children.

[0003] In order to render blister packages resistant to access bychildren, improved child-resistant blister packages have been developed.Exemplary structures of such child-resistant blister packages, as wellas exemplary methods of forming such packages, are disclosed in U.S.Pat. No. 6,161,699 to Gartland, which is hereby incorporated byreference herein.

[0004] Despite the fact that such child-resistant packages have improvedsafety characteristics, there is room for further improvements. Many ofthe known package-forming methods and package constructions, althoughoffering varying degrees of child resistance, sometimes compromisedaccessibility. Specifically, in some cases, known methods andconstructions made the product so inaccessible that even adults hadtrouble accessing the product. This later case is especially problematicwhere older adults or others who have lost some degree of manualdexterity are the users of the products.

[0005] Thus, there remains a need for an improved packaging method andconstruction that provide the desired level of resistance to a childwhile maintaining acceptable levels of accessibility for adults.

SUMMARY OF THE INVENTION

[0006] The present invention provides a child-resistant package for adosed-form product comprising a film blister layer, a rupturable layerdisposed adjacent the film blister layer, the rupturable layer and thefilm blister layer together defining at least one cavity, means forresisting passage of a dose, the means disposed adjacent the rupturablelayer on a side of the rupturable layer opposite the film blister layer,and a backing layer having at least one moveable tab corresponding tothe at least one cavity, the backing layer disposed adjacent the meansfor resisting on a side of the means opposite the rupturable layer.

[0007] An alternative embodiment of the present invention includes achild-resistant package for a product comprising a film blister layer, arupturable layer disposed adjacent the film blister layer, therupturable layer and the film blister layer together defining at leastone cavity, a diaphragm layer having at least one slit corresponding tothe at least one cavity in the film blister layer, the diaphragm layerdisposed adjacent the rupturable layer on a side of the rupturable layeropposite the film blister layer, and a backing layer having at least onemoveable tab corresponding to the at least one slit in the diaphragmlayer, the backing layer disposed adjacent the diaphragm layer on a sideof the diaphragm layer opposite the rupturable layer.

[0008] Also included as a part of the invention is a method for forminga child-resistant package for a product. The method comprises the stepsof: (a) placing a product in a cavity formed in a blister cover, (b)disposing a barrier adjacent the blister cover, thereby containing theproduct between the blister cover and the barrier, (c) disposing adiaphragm layer adjacent the barrier layer, the diaphragm layer havingat least one slit corresponding to the at least one cavity; and (d)disposing a backing layer adjacent the diaphragm layer, the backinglayer having at least one peel-away tab corresponding to the at leastone slit of the diaphragm layer.

[0009] In a more preferred method, the method comprises the steps of:(a) sealing a plurality dosages between a foil layer and a blisterlayer, (b) adhering a diaphragm layer to the foil layer such that slitsin the diaphragm correspond to dosages sealed between the foil andblister layers, and (c) adhering a backing layer to the diaphragm layersuch that a moveable tab in the backing layer corresponds to each slitin the diaphragm layer.

BRIEF DESCRIPTION OF THE FIGURES

[0010] The features of the invention believed to be novel and theelements characteristic of the invention are set forth withparticularity in the appended claims. The figures are for illustrationpurposes only and are not drawn to scale. The invention itself, however,both as to organization and method of operation, may best be understoodby reference to the detailed description that follows taken inconjunction with the accompanying drawings in which:

[0011]FIG. 1 is a cross-sectional side view of a portion of oneembodiment of the present invention which includes an optional cardlayer on top; and

[0012]FIG. 2 is an expanded view of the embodiment shown in FIG. 1 butwithout the optional card layer.

DETAILED DESCRIPTION OF THE INVENTION

[0013] The present invention includes child-resistant packages andmethods for packaging dose form products. Generally, the packagesaccording to the present invention are formed with a plurality of layersfor the packaging of dosed products within a blister or othercompartment formed between two of the layers. The products which can bepackaged in accordance with the present invention include many types,most notably dose form products such as pharmaceuticals in pill orcapsule form. Other products to which the present invention can beapplied include, without limitation, medicaments (in pill, tablet,capsule, or lozenge form), drugs, vitamins, cosmetics, foods,nutriceutical products, pharmaceutical products, devices, and any otherproduct for which dose-form consumption, or use, is desired.

[0014] This invention will now be described with reference to specificembodiments selected for illustration in the figures. It will beappreciated that the spirit and scope of this invention is not limitedto the embodiments selected for illustration. Instead, the scope of thisinvention is defined separately in the appended claims. Also, it will beappreciated that the drawings are not rendered to any particularproportion or scale.

[0015] The package of the present invention is formed in layers. Forexample, FIG. 1 shows a partial cross-sectional view of a package 10that accommodates a dose in each of a plurality of blister cavities 12.The package is formed by layers 14, 18, 22, 26, and optionally 30,bonded to one another by one or more adhesives 16, 20, 24, and 28. Morespecifically, backing layer 14 is disposed against diaphragm layer 18,which in turn is disposed adjacent a rupturable layer 22 made of foil,paper, or foil-paper laminate, which in turn is disposed adjacentblister layer 26. Backing layer 14 is preferably a paper, plastic, foilor polymer backing layer that is bonded to diaphragm layer 18 by anadhesive 16. In turn, diaphragm layer 18 is bonded to rupturable 22 byan adhesive 20. In turn, rupturable layer 22 is bonded to a blisterlayer 26 by an adhesive 24. Finally, blister layer 26 is optionallybonded to an optional card layer 30 by an adhesive 28. This optionalcard layer 30 would preferably include printed indicia or information,such as advertising or dosage instructions, among other pieces ofinformation. A preferred optional card layer is one provided byPermalith, Inc. under its mark, Permapack.

[0016] Referring to FIG. 2, package 10 is shown in an exploded view. Thefirst component is an assembly of rupturable layer 22 and blister layer26 having a plurality of blister cavities 12. FIG. 2 shows these twolayers already adhered to each other with a suitable adhesive (includingbut not limited to pressure sensitive, heat activated or ultrasonicweldable type adhesives as discussed in more detail below). Optionalcard layer 30 is not shown in this embodiment. Assemblies of card layer30 and blister layer 26 and rupturable layer 22 are available fromPermalith Plastics, LLC of Pennsauken, N.J., under the mark PERMAPACK.

[0017] The assembly of layers 22 and 26 can contain a dose in eachcavity 12. However, additional layers, as discussed below, prevent theinadvertent removal of a dose from each cavity 12 which could occur bysimply pressing against the blister layer 26 and forcing a dose througha tear thus created in the paper or foil layer 22. It is the remaininglayers, in conjunction with rupturable layer 22 and blister layer 26,which together provide package 10 with child-resistant featuresaccording to this invention.

[0018] Disposed below rupturable layer 22, and adjacent to rupturablelayer 22, is diaphragm layer 18. Diaphragm layer 18 is adhered torupturable layer 22 with a suitable adhesive (discussed in more detailbelow). Diaphragm layer 18 helps to resist the removal of a dose from ablister cavity 12, but does not unduly prevent a removal, either.Specifically, diaphragm layer 18 includes a plurality of weakenedportions for resisting passage of doses therethrough. Diaphragm layer 18is one exemplary embodiment of means for resisting passage.Alternatively, such means can be any structure capable of resistingpassage and can include a slit, a perforation, a slot, or any otherweakened portion capable of resisting dose removal without preventingsuch removal.

[0019] In the embodiments shown in FIGS. 1 and 2, for example, slits 19are illustrated, each of which is positioned to correspond with ablister cavity 12 of the blister layer 26. Slits 19 in diaphragm layer18 allow the passage of a dose when a user pushes on a blister cavity 12and little or no resistance is felt on the side of diaphragm layer 18opposite rupturable layer 22. In other words, slits 19 allow passage ofa dose when the side of the slit opposite the dose side is substantiallyunobstructed. When diaphragm layer 18 is supported by backing layer 14,however, diaphragm layer 18, even with slits 19, provides significantresistance to the passage of the dose.

[0020] Backing layer 14 is provided beneath diaphragm layer 18 and isattached to diaphragm layer 18 with a suitable adhesive (discussed inmore detail below). Backing layer 14 has a plurality of tabs 15, each ofwhich is positioned to correspond to a slit 19 of diaphragm layer 18 anda blister cavity 12 of blister layer 26. Each tab 15 of backing layer 14preferably includes a perforated portion 15A to permit at least partialremoval of the tab 15 from backing layer 14. Also preferably on tab 15is a fingernail slot 15B to provide fingernail access for movement ofthe tab 15 with respect to backing layer 14. Any specific means of tabremoval, however, is envisioned as within the scope of the presentinvention for backing layer 14.

[0021] Blister layer 26 can be made from any suitable blister layermaterial known to those skilled in the art, and is preferably a clear oropaque plastic or foil type material. Exemplary materials includetransparent or translucent thermoformable materials such as polyvinylchloride or polystyrene. Rupturable layer 22 is made from any suitablepaper, foil-paper combination or foil material known to those skilled inthe art, and is preferably foil. This layer is preferably capable ofripping or otherwise tearing so as to allow removal of the dose.Diaphragm layer 18 can be formed from a plastic or paper material.Optionally, it is formed from a plastic material such as TYVEK (Tyvek isa registered trademark of E. I. du Pont de Nemours and Company fornon-woven barrier material), or another material that has relativelyincreased tear strength and puncture resistance. Similarly, backinglayer 14 can be formed from such paper, plastic, foil, polymers orlaminates thereof.

[0022] The adhesives used to join the different layers of this inventionas discussed above include any suitable adhesives which are acceptablefor the dosage which is contained therein. Typically the dosage is ahuman pharmacological product, although the invention is not limitedthereto. Federal regulations provide for suitable pharmaceuticalpackaging adhesives, as delineated in 21 C.F.R. § 175.105.

[0023] In use, a user of the package 10 lifts a tab 15 from backinglayer 14 using a fingernail or fingertip. The tab 15 lifted is eithercompletely removed or is left hanging. The user can then push againstthe top of a blister cavity 12 on blister layer 26 in order to push adose from the blister cavity 12 through rupturable layer 22, throughslit 19 of diaphragm layer 18 and out through the backing layer 14 at alocation where the tab 15 has been removed.

[0024] By requiring the sequential step of removing a tab 15 beforepushing out the dose corresponding to that particular removed tab, thepresent invention provides a child-resistant package while not requiringmuch dexterity or force. This latter feature is important in that itprovides a physically, relatively easy means of accessing a dose, whichis preferable for seniors and others having any type of dexterity orstrength problem, while still preventing children from improperlyaccessing the dose.

[0025] Also included as a part of the invention is a method for forminga child-resistant package for a product. The method comprises the stepsof: (a) placing a product in a cavity formed in a blister cover, (b)disposing a barrier adjacent the blister cover, thereby containing theproduct between the blister cover and the barrier, (c) disposing adiaphragm layer adjacent the barrier layer, the diaphragm layer havingat least one slit corresponding to the at least one cavity; and (d)disposing a backing layer adjacent the diaphragm layer, the backinglayer having at least one peel-away tab corresponding to the at leastone slit of the diaphragm layer.

[0026] In a more preferred method, the method comprises the steps of:(a) sealing a plurality dosages between a foil layer and a blisterlayer, (b) adhering a diaphragm layer to the foil layer such that slitsin the diaphragm correspond to dosages sealed between the foil andblister layers, and (c) adhering a backing layer to the diaphragm layersuch that a moveable tab in the backing layer corresponds to each slitin the diaphragm layer.

[0027] Although the invention is illustrated and described herein withreference to specific embodiments, the invention is not intended to belimited to the details shown. Rather, various modifications may be madein the details within the scope and range of equivalents of the claimsand without departing from the invention. Such modifications couldinclude those noted above, such as the use of an optional cover card, oreven additional other layers not mentioned.

What is claimed:
 1. A child-resistant package for a product comprising:a blister layer; a rupturable layer disposed adjacent the blister layer,said rupturable layer and said blister layer together defining at leastone cavity; means for resisting passage of a dose, said means disposedadjacent said rupturable layer on a side of said rupturable layeropposite said blister layer; and a backing layer having at least onemoveable tab corresponding to said at least one cavity, said backinglayer disposed adjacent said means for resisting on a side of said meansopposite said rupturable layer.
 2. The child-resistant package of claim1 wherein said means for resisting is a diaphragm layer having a slitdisposed therein.
 3. The child-resistant package of claim 1 wherein saidmeans for resisting is comprised of plastic.
 4. The child-resistantpackage of claim 1 wherein said backing layer comprises paper.
 5. Thechild-resistant package of claim 1 wherein said rupturable layercomprises foil.
 6. The child-resistant package of claim 1 wherein saidbacking layer comprises plastic.
 7. The child-resistant package of claim1 wherein said means for resisting is a diaphragm layer formed of anon-woven barrier material.
 8. The child-resistant package of claim 1wherein said backing layer is formed of a non-woven barrier material. 9.The child-resistant package of claim 1 where said rupturable layer isformed of a woven barrier material.
 10. A child-resistant package for aproduct comprising: a blister layer; a rupturable layer disposedadjacent the blister layer, said rupturable layer and said blister layertogether defining at least one cavity; a diaphragm layer having at leastone slit corresponding to the at least one cavity in said blister layer,said diaphragm layer disposed adjacent said rupturable layer on a sideof said rupturable layer opposite said blister layer; and a backinglayer having at least one moveable tab corresponding to the at least oneslit in said diaphragm layer, said backing layer disposed adjacent saiddiaphragm layer on a side of said diaphragm layer opposite saidrupturable layer.
 11. The child-resistant package of claim 10 whereinsaid diaphragm layer comprises paper.
 12. The child-resistant package ofclaim 10 wherein said backing layer comprises paper.
 13. Thechild-resistant package of claim 10 wherein said diaphragm layercomprises plastic.
 14. The child-resistant package of claim 10 whereinsaid rupturable layer comprises foil.
 15. The child-resistant package ofclaim 10 wherein said backing layer is plastic.
 16. The child-resistantpackage of claim 10 wherein said diaphragm layer is formed of anon-woven barrier material.
 17. The child-resistant package of claim 10wherein said diaphragm layer is formed of a woven barrier material. 18.The child-resistant package of claim 10 wherein said backing layer isformed of a non-woven barrier material.
 19. A method for forming achild-resistant package for a product, said method comprising the stepsof: (a) placing a product in a cavity formed in a blister cover; (b)disposing a barrier adjacent the blister cover, thereby containing theproduct between the blister cover and the barrier; (c) disposing adiaphragm layer adjacent the barrier layer, said diaphragm layer havingat least one slit corresponding to the at least one cavity; and (d)disposing a backing layer adjacent the diaphragm layer, said backinglayer having at least one peel-away tab corresponding to the at leastone slit of the diaphragm layer.
 20. The method of claim 19 wherein step(b) comprises disposing a foil layer adjacent the blister cover.
 21. Themethod of claim 19 wherein step (c) comprises disposing a plastic layeradjacent the barrier layer.
 22. The method of claim 19 wherein thebacking is formed from any one or more of film, plastic, non-wovenbarrier material, woven barrier material or paper.
 23. A method ofpackaging a dosed product comprising the steps of: (a) sealing aplurality dosages between a foil layer and a blister layer; (b) adheringa diaphragm layer to the foil layer such that slits in the diaphragmcorrespond to dosages sealed between the foil and blister layers; and(c) adhering a backing layer to the diaphragm layer such that a moveabletab in the backing layer corresponds to each slit in the diaphragmlayer.